appendix a

89 Pages·2010·0.54 MB·English

by  Tanya Bobo

APPENDIX A
Spinal Injections

©Institute for Clinical and Economic Review, 2010 1
Introduction
Spinal injections are of clinical interest in low back pain because medication is directly
delivered to the anatomic location that has been identified as the likely source of pain.
Depending upon the type of injection, some injections may bring about long-lasting relief
while others may only provide temporary relief. Several spinal injections are used in
practice today. They can be classified as either intraspinal injections or injections outside
the spine. Intraspinal injections are further categorized into either intraspinal steroid
injections or chemonucleolysis. These include:

Intraspinal injections
• Intraspinal steroid injections
Epidural steroid injection
-
Facet joint steroid injection
-
Sacroiliac joint steroid injection
-
Intradiscal steroid injection
-

• Nerve blocks
Medial branch blocks
-
Sympathetic nerve blocks
-
Selective nerve root blocks
-

• Chemonucleolysis

Injections outside the spine
• Botulinum toxin injections
• Local injections
• Prolotherapy

Intraspinal injections
Intraspinal steroid injections
Epidural steroid injections (ESIs) deliver the steroid into the epidural space, the space
between the dura and the spine. The injection typically includes both a long-lasting
steroid and a local anesthetic. ESIs may be delivered in three different ways. The
transforaminal approach delivers the needle to the neural foramen, the space through
which nerve roots exit the spinal canal to form the peripheral nerves. Interlaminar (or
translaminar) injections deliver steroid directly into the epidural space. Finally, caudal
injections approach the epidural space by going through the sacral opening.

Additional types of steroid injections have other anatomic targets. Facet joint steroid
injections deliver corticosteroids into the facet joints, joints that are located between and
behind adjacent vertebrae. Sacroiliac joint steroid injections are corticosteroid injections
into or around the sacroiliac joint, the joint that connects the sacrum to the pelvis.
Intradiscal steroid injections involve injecting a corticosteroid into an intervertebral disc
to treat discogenic pain.

©Institute for Clinical and Economic Review, 2010 2
Nerve blocks
Nerve block injections include an anesthetic and may also include a corticosteroid.
These injections are intended to target specific areas thought to be the source of pain,
temporarily blocking pain signals. Most commonly, these injections target the medial
branch nerves, which emanate from the facet joints and in turn carry pain signals from
these joints. Nerve-blocking injections may also target the sympathetic nervous system,
which control some of the body’s involuntary functions.

Finally, nerve blocks may target selective nerve roots. These injections are intended
primarily to diagnose the source of pain, not to treat it.

Chemonucleolysis
Chemonucleolysis uses a proteolytic enzyme, usually chymopapain, to dissolve the
inner part of a herniated disc, in an effort to resolve radicular pain.

Injections outside the spine
Injections that take place outside of the spine target the muscles or the soft tissues of the
back. Botulinum toxin (Botox) injections are injected into the muscles of the back to control
muscle spasms. Local injections utilize a local anesthetic, injected into the muscles or soft
tissues of the back. These are used to treat inflammation in small areas of the back.
Prolotherapy is a procedure in which a chemical irritant is injected into the soft tissues of
the back. This promotes an inflammatory response, which is thought to lead to a natural
healing that will strengthen the injured soft tissue and thus, reduce back pain. Also known
as sclerotherapy, it is used to treat sciatica and degenerative disc disease.

Each type of injection procedure may last between 15 and 30 minutes. The patient lies on
an X-ray table and the skin in the lower back area is cleaned and numbed with a local
anesthetic. Spinal injections are best done under fluoroscopic (live X-ray) guidance. Once
the needle is in the proper position, a contrast dye is injected to confirm the position of the
needle. Following confirmation, the steroid/anesthetic solution is injected.

Risks associated with these procedures include misplacement of the needle (either
advancing the needle too deeply or placing it in the wrong position). The outcomes of
incorrect needle position include nerve damage, infection, bleeding, and headaches. Risks
associated with the medications include elevated blood sugars, arthritis, stomach ulcers,
and weight gain. Chemonucleolysis may also cause anaphylactic reactions in some
patients.

One risk specifically associated with epidural steroid injections is wet tap, in which the
needle penetrates the spinal sac and enters the cerebrospinal fluid. This causes the fluid to
leak, resulting in severe headaches. Other rare complications associated with epidural
steroid injections include epidural hematoma and abscess.

©Institute for Clinical and Economic Review, 2010 3
Professional Organization and Agency Recommendations

American Society of Anesthesiologists Task Force on Chronic Pain Management
and the American Society of Regional Anesthesia and Pain Medicine (2010)
http://journals.lww.com/anesthesiology/Fulltext/2010/04000/Practice_Guidelines
_for_Chronic_Pain_Management_.13.aspx
Intra-articular facet joint injections may be used for symptomatic relief of facet-
mediated pain. Sacroiliac joint injections may be considered for symptomatic relief
of sacroiliac joint pain. Medial branch blocks may be used for treatment of facet-
mediated pain. Epidural steroid injections with or without local anesthetics may be
used as part of a multimodal treatment regimen in select patients with
radiculopathy.

The American Pain Society (APS, 2009)
http://journals.lww.com/spinejournal/Abstract/2009/05010/Interventional_Thera
pies,_Surgery,_and.14.aspx
In patients with persistent nonradicular low back pain, facet joint corticosteroid
injection and intradiscal corticosteroid injection are not recommended because
randomized trials consistently found them to be no more effective than sham
therapies. In patients with persistent radiculopathy due to a herniated lumbar disc,
it is recommended that clinicians discuss the risks and benefits of epidural steroid
injection as a treatment option. It is also recommended that any shared decision-
making regarding epidural steroid injection include a specific discussion about
inconsistent evidence showing moderate short-term benefits and the lack of long-
term benefits. There is little evidence to sufficiently assess the benefits and harms of
epidural steroid injection for spinal stenosis.

American Society of Interventional Pain Physicians (AIPP, 2009)
http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf
Based on the quality of evidence, the use of therapeutic lumbar facet joint nerve
blocks for both short-term and long-term relief is strongly recommended. For those
with either lumbar spinal pain with disc herniation and radiculitis, or discogenic
pain without disc herniation, or radiculitis, the use of epidural steroid injections is
strongly recommended. For those with disc herniation and radiculitis, lumbar
interlaminar epidural injections are strongly recommended for short-term relief,
although this recommendation may change when higher quality evidence becomes
available. Interlaminar epidural injections are not highly recommended for long-
term relief. For those with spinal stenosis and discogenic pain without disc
herniation and radiculitis, the use of lumbar intralaminar epidural injection is not
highly recommended. For managing chronic low back and lower extremity pain, the
use of transforaminal epidural injections is strongly recommended.

©Institute for Clinical and Economic Review, 2010 4
American Association of Neurological Surgeons/Congress of Neurological
Surgeons Joint Section on Disorders of the Spine and Peripheral Nerves
(AANS/CNS, 2005)
http://www.spinesection.org/fusion_guidelines.php
The use of facet epidural injections or lumbar epidural injections is not
recommended for long-term treatment of low back pain. The use of lumbar epidural
injections is recommended, however, as a treatment option that provides temporary,
symptomatic relief in selected patients with low back pain.

Recent Technology Assessments

Canadian Agency for Drugs and Technologies in Health (CADTH, 2007)
http://www.cadth.ca/media/pdf/I3003_tr_Facet_Joint_Injections_e.pdf. Facet
joint injections should be used as an adjunct to other forms of conservative
treatment, such as physical exercise, rather than as a stand-alone treatment.

The Cochrane Collaboration (2009)
http://www2.cochrane.org/reviews/en/ab001824.html
There is not enough evidence to recommend the use of injection therapy for sub-
acute and chronic low back pain.

Institute for Clinical Systems improvement (2004)
http://www.icsi.org/technology_assessment_reports_-
_active/ta_fluoroscopically_guided_transforaminal_epidural_steroid_injections_for
_lumbar_radicular_pain.html
When performed by an experienced physician, fluoroscopically-guided epidural
steroid injections are generally safe. There is limited information, however, to
comment on the short- or long-term efficacy of epidural steroid injections.

Coverage Policies

Centers for Medicare and Medicaid Services (CMS): Medicare currently does not
have a National Coverage Determination (NCD) for spinal injections.
Representative local coverage determinations for epidural and transforaminal
epidural injections indicate that both types of injections may only be used in the
presence of radiculopathy. Therapeutic facet joint/nerve block injections may be
considered for coverage provided that:
• Injections do not exceed a frequency parameter of more than once every two
(2) months for a specific region (cervical/thoracic, lumbosacral);
• Initial pain relief of greater than or equal to (≥) 80%-90% with the ability to
perform previously painful maneuvers and persistent pain relief for a
minimum of six (6) weeks of ≥ 50% with the continued ability to perform
previously painful maneuvers; and

©Institute for Clinical and Economic Review, 2010 5
• Appropriate consideration is given to the adverse effects (e.g., adrenal
suppression of corticosteroid injections).

Aetna: Aetna considers any of the following injections or procedures medically
necessary for the treatment of back pain; provided, however, that only one invasive
modality or procedure will be considered medically necessary at a time.
• Epidural steroid injections are considered medically necessary when:
1. Intraspinal tumor or other space-occupying lesion has been ruled out
as a cause of pain; and
2. The patient has failed to improve after two or more weeks using
conservative measures; and
3. Epidural steroid injections beyond the first set of three injections are
provided as part of a comprehensive pain management program.
• Selective nerve root blocks are considered medically necessary in the
treatment of persons with radiculopathy when non-invasive measures have
failed and when any of the following conditions are met:
1. Radicular pain is due to post-surgical or post-traumatic scarring; or
2. Radicular pain when a surgically correctable lesion cannot be
identified; or
3. Radicular pain in persons with surgically correctable lesions but who
are not surgical candidates.

Humana: Humana members may be eligible for epidural steroid injections for back
and neck pain when all of the following criteria are met:
1. Failure to improve after six weeks of conservative therapy; and
2. Pain is radicular in nature; and
3. With low back pain, radicular pain radiates below the knee.
Members may be eligible for lumbar facet joint injections or medical branch nerve
blocks when all of the following criteria are met:
1. Absence of radiculopathy; and
2. Since initial diagnosis, back pain is not responsive to conservative therapy;
and
3. There are no more than three levels of facet joint injections per side, per
region; and
4. Pain is aggravated by rotation, extension, or lateral bending of the spine and
is not associated with neurological deficits.

UnitedHealthCare: Facet joint injections are unproven for the treatment of chronic
spinal pain while epidural steroid injections are proven for treatment of sub-acute
sciatica or low back radicular pain caused by disc herniation or degenerative
changes in the vertebrae. Epidural steroid injections have a role in short-term
management of low back pain when the symptoms of nerve root irritation and/or
low back pain are due to disc extrusions and/or contained herniations and pain has
been unresponsive to conservative treatment.

©Institute for Clinical and Economic Review, 2010 6
Ongoing Research (from www.clinicaltrials.gov)

Trial Sponsor, NCT ID Design Primary Populations Variables Estimated
Number/Title Outcomes Study
Completion
Date
Franklin Pierce RCT Change in • 50 Years to Epidural May 2011
University|University of disability as 90 Years steroid injection
Colorado, Denver, measured by • N=80 plus physical
NCT00786981/Epidural the Modified therapy vs.
Steroid Injection Versus Oswestry Epidural
Epidural Steroid Injection Disability steroid injection
and Manual Physical Index
Therapy and Exercise in the
Management of Lumbar
Spinal Stenosis; a
Randomized Clinical Trial
Coastal Orthopedics & RCT Changes in • 18 Years MILD® June 2011
Sports Medicine|Vertos back pain (as and older (Minimally
Medical, Inc., by Visual • N=40 Invasive
NCT00995371/Study of Analog Scale; Lumbar
Epidural Steroid Injection Changes in Decompression)
(ESI) Versus Minimally quality of life vs. Epidural
Invasive Lumbar on SF-12; Steroid
Decompression (MILD®) in change in Injection
Patients With Symptomatic function as
Lumbar Central Canal measured by
Stenosis the Oswestry
Disability
Index and
Zürich
Claudication
Questionnaire
Pain Management Center of RCT Numeric • 18 Years Caudal January 2014
Paducah, NCT01053273/A rating scale and older Epidural
Randomized, Equivalence (NRS), • N=120 Injection vs.
Trial of Percutaneous Oswestry percutaneous
Lumbar Adhesiolysis and Disability adhesiolysis
Caudal Epidural Steroid Index (ODI),
Injections duration of
significant
pain relief,
opioid intake,
and return to
work

©Institute for Clinical and Economic Review, 2010 7
APPENDIX B
Radiofrequency Denervation and Intradiscal Electrothermal Therapy

©Institute for Clinical and Economic Review, 2010 8
Introduction

Radiofrequency denervation

Radiofrequency denervation (also known as radiofrequency neurotomy) is a type of
injection procedure that uses heat to cauterize the affected nerve(s) thought to be associated
with back pain. This procedure attempts to interrupt pain signals from these nerves,
thereby reducing pain perception by the brain.

On the day of the procedure, patients are advised to avoid engaging in any strenuous
activities. Patients may continue to take their normal medications except for blood-thinning
medications. The patient lies face down on an X-ray table. The skin over the lower back is
cleaned and numbed. The physician uses fluoroscopy to help advance the placement of the
needle into the desired location. A small amount of current is passed through the needle to
ensure that it is next to the target nerve; this may briefly cause facet joint or sacroiliac pain.
The nerves are then numbed to minimize facet or sacroiliac joint pain while the lesion is
being created. The process is repeated for up to 1-5 additional nerves. The entire
procedure can last between 30 and 90 minutes and is performed in an outpatient setting.
Patients are usually able to resume their normal activities in a short period. Risks
associated with this procedure include pain or discomfort around the injection site,
worsened facet or sacroiliac joint pain, permanent nerve pain, infection, and bleeding.

Intradiscal electrothermal therapy (IDET)

IDET involves the insertion of a probe into the disc(s) thought to be the source of pain and
application of heat through a catheter in the disc. It is not known how IDET reduces pain.
Proposed mechanisms of action include thermal destruction of nerve endings in the
posterior disc wall; thickening of the collagen, which changes its form, thus destroying the
painful nerves near the disc; stimulation of new collagen formation; and destruction of
inflammatory or pain mediators within the disc tissue.

Using X-ray guidance, an electrothermal catheter is inserted through a needle and guided
into the proper position. The temperature of the catheter is slowly increased to 90° Celsius
(195° Fahrenheit). The heat shrinks and repairs the tears in the disc wall. The catheter is
removed and the disc is then injected with small amounts of antibiotic and anesthetic to
reduce the risk of infection and diminish discomfort, respectively. The procedure is
performed on an outpatient basis. Several discs may be treated during a single session.
The most common complaint is mild irritation at the needle insertion site after the local
anesthetic has worn off. Other risks associated with the procedure include bleeding,
infection, and nerve damage.

©Institute for Clinical and Economic Review, 2010 9
Professional Organization and Agency Recommendations

Radiofrequency Denervation

American Society of Anesthesiologists Task Force on Chronic Pain Management
and the American Society of Regional Anesthesia and Pain Medicine (2010)
http://journals.lww.com/anesthesiology/Fulltext/2010/04000/Practice_Guidelines
_for_Chronic_Pain_Management_.13.aspx
Radiofrequency ablation of the medial branch nerves to the facet joint should be
performed for low back pain when previous therapeutic injections have provided
temporary relief. Radiofrequency ablation of the dorsal root ganglion should not be
routinely used in the treatment of lumbar radicular pain.

The American Pain Society (APS, 2009)
http://journals.lww.com/spinejournal/Abstract/2009/05010/Interventional_Thera
pies,_Surgery,_and.14.aspx
There is insufficient evidence to adequately evaluate the benefits of radiofrequency
denervation for patients with persistent nonradicular low back pain. The evidence
supporting the use of radiofrequency denervation for low back pain is limited.
Though radiofrequency denervation appears to be safe, there appears to be a trend
towards increased pain immediately after the procedure as compared to sham
denervation.

American Society of Interventional Pain Physicians (AIPP, 2009)
http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf
The level of evidence for lumbar radiofrequency neurotomy is limited. Despite the
limited evidence for radiofrequency neurotomy, the procedure is strongly
recommended for the management of low back pain.

Intradiscal Electrothermal Therapy

American Society of Anesthesiologists Task Force on Chronic Pain Management
and the American Society of Regional Anesthesia and Pain Medicine (2010)
http://journals.lww.com/anesthesiology/Fulltext/2010/04000/Practice_Guidelines
_for_Chronic_Pain_Management_.13.aspx
IDET may be considered for young active patients with early single-level
degenerative disc disease and well-maintained disc height.

The American Pain Society (APS, 2009)
http://journals.lww.com/spinejournal/Abstract/2009/05010/Interventional_Thera
pies,_Surgery,_and.14.aspx
There is insufficient evidence to evaluate adequately, the benefits of IDET for
patients with persistent nonradicular low back pain.

©Institute for Clinical and Economic Review, 2010 10